Baxter International Inc.
Research Scientist II - Study Director,
Baxter International Inc., Round Lake, Illinois, United States, 60073
Join to apply for the
Research Scientist II - Study Director
role at
Baxter International Inc.
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they come from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact.
Your Role at Baxter As a Research Scientist II, Study Director, you will be at the forefront of designing and leading E&L studies for medical devices and drug product packaging. You will ensure alignment with industry standards such as ISO 10993-18 and USP, while pushing the boundaries of scientific inquiry. Your expertise will guide the development of E&L strategies that not only meet regulatory requirements but also support innovative product development.
What You’ll Be Doing
Innovative Study Design: Collaborate with subject matter experts (SMEs) to craft comprehensive E&L studies that adhere to rigorous scientific and regulatory standards.
Leadership in Research: Lead and coordinate E&L studies both internally and at external laboratories, ensuring high-quality execution with minimal oversight.
Cross-Functional Collaboration: Engage with diverse teams across chemistry, biocompatibility, regulatory affairs, program management, manufacturing, and toxicology to drive project success.
Regulatory Engagement: Interact with regulatory authorities for product submissions, pre-submission meetings, and addressing queries, ensuring our products meet the highest standards of safety and efficacy.
Study Direction: Design and supervise the execution of E&L studies, including method development, validation, and transfer, while authoring protocols and reports that incorporate insights from various SMEs.
Strategic Development: Formulate E&L strategies that align with regulatory pathways, biocompatibility considerations, and customer needs to ensure our products are both innovative and safe for patients.
Data Analysis: Review E&L data to identify trends and correlations with materials of construction. Focus on the structural identification of E&L compounds and collaborate with the Biocompatibility team on toxicological risk assessment.
Investigation Leadership: Lead scientific investigations as part of E&L studies, applying critical thinking to derive conclusions based on sound scientific principles.
Quality Assurance: Maintain a deep understanding of Quality System Regulations and ensure compliance in all research activities, data collection, and reporting.
What You’ll Bring
Educational Background: A Bachelor’s degree in a scientific discipline is required, with 10 years of experience; an MS with 5-7 years; or a PhD with 3 years in a relevant field.
E&L Expertise: Proven experience in E&L studies, analytical test method development, and validation is essential.
Analytical Proficiency: Strong knowledge of analytical chemistry techniques (e.g., LC/MS/UV, GC/MS/FID, ICP-MS) and chemical characterization standards for medical devices and drug packaging.
Regulatory Knowledge: Familiarity with regulations governing extractables and leachables, particularly for Container Closure Systems and medical devices.
People Management Experience: Previous experience with people management is highly desirable.
Team Player: Ability to work collaboratively in a team environment, embracing diversity and fostering an inclusive culture.
Compensation and Benefits The estimated base salary for this position is $120,000 to $165,000 annually. Baxter is committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
#J-18808-Ljbffr
Research Scientist II - Study Director
role at
Baxter International Inc.
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they come from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact.
Your Role at Baxter As a Research Scientist II, Study Director, you will be at the forefront of designing and leading E&L studies for medical devices and drug product packaging. You will ensure alignment with industry standards such as ISO 10993-18 and USP, while pushing the boundaries of scientific inquiry. Your expertise will guide the development of E&L strategies that not only meet regulatory requirements but also support innovative product development.
What You’ll Be Doing
Innovative Study Design: Collaborate with subject matter experts (SMEs) to craft comprehensive E&L studies that adhere to rigorous scientific and regulatory standards.
Leadership in Research: Lead and coordinate E&L studies both internally and at external laboratories, ensuring high-quality execution with minimal oversight.
Cross-Functional Collaboration: Engage with diverse teams across chemistry, biocompatibility, regulatory affairs, program management, manufacturing, and toxicology to drive project success.
Regulatory Engagement: Interact with regulatory authorities for product submissions, pre-submission meetings, and addressing queries, ensuring our products meet the highest standards of safety and efficacy.
Study Direction: Design and supervise the execution of E&L studies, including method development, validation, and transfer, while authoring protocols and reports that incorporate insights from various SMEs.
Strategic Development: Formulate E&L strategies that align with regulatory pathways, biocompatibility considerations, and customer needs to ensure our products are both innovative and safe for patients.
Data Analysis: Review E&L data to identify trends and correlations with materials of construction. Focus on the structural identification of E&L compounds and collaborate with the Biocompatibility team on toxicological risk assessment.
Investigation Leadership: Lead scientific investigations as part of E&L studies, applying critical thinking to derive conclusions based on sound scientific principles.
Quality Assurance: Maintain a deep understanding of Quality System Regulations and ensure compliance in all research activities, data collection, and reporting.
What You’ll Bring
Educational Background: A Bachelor’s degree in a scientific discipline is required, with 10 years of experience; an MS with 5-7 years; or a PhD with 3 years in a relevant field.
E&L Expertise: Proven experience in E&L studies, analytical test method development, and validation is essential.
Analytical Proficiency: Strong knowledge of analytical chemistry techniques (e.g., LC/MS/UV, GC/MS/FID, ICP-MS) and chemical characterization standards for medical devices and drug packaging.
Regulatory Knowledge: Familiarity with regulations governing extractables and leachables, particularly for Container Closure Systems and medical devices.
People Management Experience: Previous experience with people management is highly desirable.
Team Player: Ability to work collaboratively in a team environment, embracing diversity and fostering an inclusive culture.
Compensation and Benefits The estimated base salary for this position is $120,000 to $165,000 annually. Baxter is committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
#J-18808-Ljbffr